Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
466 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Beaver Visitec International Inc, FA-23-002, Conventional Crescent Knife 2.5mm, 55 degrees
BVI heeft feedback van een enkele klant ontvangen dat één partij van het artikelnummer 373807, conventioneel mes met gebogen ...
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Zimmer Surgical, Inc., ZFA2023-00208, Zimmer® Dermatome Blades
There have been 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades. The ...
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Thommen Medical AG, 23/01, SPI®ELEMENT impl. RC INICELL®
Thommen Medical AG is carrying out a recall of a batch of article 4.23.142 "SPI ELEMENT RC INICELL, implant incl. healing cap PF ...
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Biocomposites Ltd., CC00916, GeneX DS 2.5cc and GeneX DS 5cc
The Indications should state that ‘genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the ...
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PEROUSE MEDICAL, CAPA23-051, POLYFILM
A sealing problem on the packaging of the POLYFILM® has occurred. If the packaging of POLYFILM® has a defective sealing, it can ...
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Arthrex INC, R537_NL, Knee Scorpion™
Associated outer labels and label content document for indicated batches display a sterility statement indicating “sterile” via ...
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Ethicon LLC, 2283226 (2) - PDS Clear Suture Breakage Complaints, PDS II Suture
lnternal testing on returned product from this lot confirmed that some POS™ Il (polydioxanone) Sutures from this lot did not meet ...
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St. Jude Medical, FA-Q123-SH-2 Trifecta, Trifecta Valve, Trifecta Valve w. Glide Technology
Op 27 februari 2023 heeft Abbott al laten weten dat de mogelijkheid van Structural Valve Deterioration (Structurele ...
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MAQUET Cardiovascular, LLC, 2242352-06/20/2023-003-R, ACCESSRAIL Platform and Acrobat Systems
Maquet/Getinge is initiating a voluntary Medical Device Field Safety Notice-Removal for the ACCESSRAIL Platform Standard Blade ...
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Equimedical BV, 2-2023, Equitamp and Equicel and equispon
In March 2023 the Health and Youth Care Inspectorate (NL) received a compliance and enforcement request (CEF) fom Agentia ...